【每日一句(段)有奖翻译】<三十> Monograph Components(5)

影子

2011/01/18

私聊

专业英语

这段话太长了点：
In Compounded Preparations

1. Compounded preparations for which a complete composition is given shall contain only the ingredients
named in the formulas unless specifically exempted herein or in the individual monograph.

2. Deviation from the specified processes or methods of compounding, although not from the ingredients
or proportions thereof, may occur provided that the finished preparation conforms to the relevant standards
and to preparations produced by following the specified process.

3. Where a monograph for a compounded preparation calls for an ingredient in an amount expressed on
the dried basis, the ingredient need not be dried before use if due allowance is made for the water or other
volatile substances present in the quantity taken.

4. Specially denatured alcohol formulas are available for use in accordance with federal statutes and
regulations of the Internal Revenue Service.

5. A suitable formula of specially denatured alcohol may be substituted for Alcohol in the manufacture of
official preparations intended for internal or topical use, provided that the denaturant is volatile and does
not remain in the finished product.

6. A preparation that is intended for topical application to the skin may contain specially denatured alcohol,
provided that the denaturant is either a usual ingredient in the preparation or a permissible added
substance; in either case the denaturant shall be identified on the label of the topical preparation.

7. Where a process is given in the individual monograph, any preparation compounded using denatured
alcohol shall be identical to that prepared by the monograph process.

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f4forever

第1楼2011/01/18

在复方制剂中

1.已给出完整组成的复方制剂中只能包含配方中列出的成分，除非在此或在相应专论中明确说明含有配方以外的成分。

2.只要制剂成品符合相应标准并且其质量与按指定工艺生产出来的制剂成品质量一致，可以不按指定的工艺或方法进行合成，但其中的成分及其组成比例不可发生变化。

3.当复方制剂的专论对某一成分的含量规定基于干品作出时，如果相应规定了用量中水分或其他挥发性物质的限量，那么使用该成分前无需干燥。

4.根据联邦法规和国税局的规定，变性醇配方可以使用。

5.生产内服或外用的法定制剂时可以用合适的变性醇配方替代乙醇，只要该变性剂易挥发且在最终成品中无残留。

6.皮肤外用制剂可以含有变性醇，只要该变性剂是制剂常用成分，或者是允许添加的物质；不管是何种情况，变性剂的使用都须在外用制剂的标签上说明。

7.如果专论中给出了生产工艺，那么使用变性醇生产的制剂应与通过该工艺生产出来的制剂质量一致。